BioDelivery Sciences International, Inc. (BDSI)

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BioDelivery Sciences International, Inc. (BDSI)

R&D Day Conference

March 7, 2013 12:00 ET


Mark Sirgo - President and Chief Executive Officer

Dr. Joe Pergolizzi - Pain Medicine Specialist, Assistant Professor of Medicine, Johns Hopkins School of Medicine

Dr. Andrew Finn - Head of Product Development

Dr. Greg Sullivan - Addiction Medicine Specialist, Parkway Medical Center, Birmingham, Alabama

Al Medwar - Head of Corporate Development and Marketing

Dr. Genie Bailey - Addiction Medicine Specialist, Medical Director, Stanley St. Treatment and Resources Faculty, Brown University


Mark Sirgo

Good afternoon, everyone. I am Mark Sirgo, the President and CEO of BioDelivery Sciences. We are pleased to have you join us today for what we believe will be a very provocative and educational program. Now, while I am providing some opening remarks, I’d ask you to please take a look at our forward-looking statements on this next slide.

We plan to cover two very relevant therapeutic topics today that include the treatment of chronic pain with opioids focusing on BEMA Buprenorphine and the treatment of opioid dependence would focus on Buprenorphine/Naloxone or our BNX product. To assist us with this program today, we have had a group of outstanding physicians who have hands-on experience in not only treating these conditions, but also in using our Buprenorphine products through their participation in our clinical trial programs. We will also be sharing with you some clinical and pharmacokinetic data that has not been shared before as we update you on the status of our two extremely important clinical development programs for the company.

Our objective behind today is presentations, is to have you leave here with the understanding that Buprenorphine is just not another opioid for treating pain. And two, that BNX offers meaningful differences compared to the market leader Suboxone. We believe both products are going to make substantial differences in the marketplace in the lives of the patients that we will be treating.

So, let me quickly review our agenda for today and our corresponding presenters for whom you have been provided biographical sketches, so I won’t repeat that here. First, we have Dr. Joe Pergolizzi reviewing the unique pharmacological properties of Buprenorphine and how these made translate into patient benefits and treating chronic pain. Dr. Pergolizzi will be followed by Dr. Andrew Finn who is BDSI’s Head of Product Development. Dr. Finn will be providing insight into our Phase 3 Buprenorphine chronic pain program that we have partnered with Endo. Dr. Finn will be followed by Dr. Greg Sullivan. Dr. Sullivan will educate us on opioid dependency in its treatment with Buprenorphine.

Following Dr. Sullivan’s presentation, Dr. Finn will rejoin us to provide an update on our BNX NDA program, and in doing so providing data not yet previously disclosed. We will then the close the formal presentation with Al Medwar, who is BDSI’s Head of Corporate Development and Marketing. Al will cover the market opportunities for a two Buprenorphine products. We will then move to Q&A, where Dr. Genie Bailey, Psychiatrist and Addiction Specialist would join us along with Dr. Pergolizzi and Dr. Sullivan to answer any questions that you may have. And we will be passing out cards during the course of today’s presentation whereby you can list your questions. We will do our best to answer each and every one of those before the session is completed. The presenters will also remain here after the close of the presentation to answer additional questions that you may have.

So, with that, I would like to turn the podium over to Dr. Pergolizzi. Thank you.

Joe Pergolizzi

Thank you very much, Mark. Thank you all for coming out and braving the weather today. You can see from my affiliations that I split time at various medical schools in different departments, so in Johns Hopkins in the Department of Medicine, at Georgetown in the Department of Anesthesia and Pain Medicine, and at Temple, I am in the Department of Pharmacology.

I do that while also practicing down in Naples, Florida taking care of older patients. And all of you are welcome to Naples, come visit me anytime you like. It’s jut you are about 30 years too young right now. This is what we are all missing today by not being in Naples. So, but I am also missing this right, my good colleagues and friends that I take care of down in the Naples Beach area.

And again, you are invited to come visit me in any of my institutions if you like, because today we are going to talk about pain and the unique opportunity that Buprenorphine brings to the chronic pain market. And I can tell you this that pain, chronic pain is on the present due to the epidemiological prevalence here in the United States. It’s about 14.5% the adult population and the most conservative CDC reports, that’s approximately 42.5 million adult Americans that are complaining of chronic pain average annually. And then you have other reports that the chronic pain over 100 million patients and the burden related to healthcare dollars is about $600 billion a year. We have no one golden bullet currently that works in 100% of the patients, 100% of the time without adverse events, and we are in very much need of products like this.

So, today, I am just going to give you my understanding of Buprenorphine, and how I think it can help chronic pain here in the United States. So, let’s look at some of those areas of interest related to the point prevalence. Here, again another CDC National Survey says that about 100 million adults in the United States suffered from chronic pain. So, think about other hallmarks for chronic disease. That means the prevalence is higher than combining hypertension or a cardiovascular disease, diabetes, and cancer. So, it’s on the present and ever growing, particularly with the population period with upside down, more and more people who present with chronic pain. And it’s the primary reason for healthcare access in the United States. It has been inadequately managed or reported to be adequately managed in about 60% of the patients, and part of it is we just have to appreciate that pain is very subjective, and there is lots of variability when it comes to it. It’s not uncommon that we have to use multi-mechanistic meaning two analgesics together or multimodal therapy meaning non-pharmacological therapy with pharmacological therapy.

An important aspect of chronic pain is that we are never looking to totally remove the patients’ pain. So, we are more or less very focused on improving quality-of-life and other outcome measurements like activities of daily living and functioning in patient satisfaction. So, when you think about an ideal analgesic and you think about what this formulation of Buprenorphine brings to our patients is start to realize why, it’s so attractive to pain specialists like myself.

There are gaps in the management of pain, and this is mainly due to concerns related to safety and tolerability. There is, if you can imagine this, there is very delicate vicious circle with the currently used compounds that we have now whereby patients may get an effect and the analgesic may work initially, but then as you increase the dose of that drug, you start to increase the tolerability or side effects to a point, where sometimes that limits your ability to use that drug. And this vicious circle is on the present problem, when it comes to management of chronic pain. So, compounds that may mitigate that or may have more universal or broad approval or appeal its application, grounded in acknowledged safety and effectiveness like Buprenorphine again become a very attractive opportunity.

So, there is a need for new analgesics and delivery technologies to improve efficacy, effectiveness, safety and tolerability. This year is the WHO Pain Ladder and it’s very interesting, because this was designed for cancer patients. And we all live in a world, where we talk about evidence-based medicines from a group that I led pan-European group, looked at the evidence we were around the WHO Pain Ladder. Unfortunately, there is not a lot of real evidence that builds this ladder, but it really is the way that we treat and handle our patients.

And we see that not just anecdotally in the clinic, but we also see that if you look at large IMS prescribing databases that it’s a stepwise approach. And this stepwise approach is really based on intensity of pain and not the mechanism of action. So, I bring your attention to that, because drugs that maybe affected across various types of mechanisms of action, no susceptive or musculoskeletal type pain, neuropathic or nerve pain or mixed pain. Drugs that have efficacy across the spectrum of different types of generators of pain are again going to be very helpful, and I’ll show you in the literature that Buprenorphine has that quality.

Now, wherever Buprenorphine fit in here, when you look at this, it’s probably going to fit somewhere around the step two part. And what we have right now currently in the United States with the only approved Buprenorphine for chronic pain, which is a low-dose transdermal patch is the ability to go around step two. When we go above that, we are limited by the dose with the currently available transdermal patch. So, what this product I think will bring for us is an ability to go to step 2.5 and above, and that’s very exciting when it comes to clinical practical use. Noting that the majority of patients who experience moderate-to-severe chronic pain have usually had that condition for about 12 years and it’s some type of now mixed pain syndrome meaning it may have started off with just as an osteoarthritis hip-related pain, but over time, your body changes and your nervous system changes and up regulates. So, that now there is a neuropathic component to that.

So, if we look at the ideal therapy for chronic pain, what should it be? Well, it should by provide continuous relief for chronic pain. Think about it if you have chronic pain, it’s like if you have chronic benign hypertension, you have that medication, which is in the background constantly working providing the continuous relief. Now, if you have chronic pain and you exacerbate you start shoveling your hard and picking up heavy things maybe you will have exacerbations on pain and that’s where immediate release on medications come. If you have cancer and you have what we call breakthrough pain, again that’s we may use rapid onset opioids and things to that effect, but continuous pain relief of chronic pain is important. Remember with the goal of not totally eradicating the pain, but providing enough analgesia, so that it’s optimal. So, we can get people back functioning and working and that’s important, the ability to have clear cognition while being on one of these divisions is extremely important, and I am going to show you study that again lends itself to believe that Buprenorphine is an excellent opportunity in that field.

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